(52 days)
Skintact ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular, patient ECG surveillance and ECG diagnosis recording.
Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.
Skintact® ECG Tab Electrodes (and as also to be offered for sale under various private label tradenames) will be offered with LecTec LT 4900 gel. Skintact ECG Tab Electrodes with LecTec LT 4900 gel are self-adhesive, non-sterile, single use disposable electrodes for diagnostic resting ECG. ECG Tab electrodes are composed of a PET tape, Ag/AgCl ink and a conductive gel, at each case 10 electrodes are applied on a one-sided siliconized transparent PET card, 10 cards are packaged in a pouch.
This document describes the 510(k) submission for Skintact® ECG Tab Electrodes with LecTec LT 4900 gel. The summary of testing focuses on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than proving performance against specific acceptance criteria for an AI-powered device. Therefore, a direct mapping to the requested table and sections for AI device studies is not fully applicable. However, I will extract the relevant information and structure it as closely as possible to your request.
Key takeaway: This is not a study of an AI device. It's a 510(k) submission for a physical medical device (ECG electrodes) demonstrating performance against standards and equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a physical ECG electrode and not an AI device, the "acceptance criteria" are derived from the ANSI/AAMI EC 12:2000 standard for Disposable ECG electrodes. The "device performance" refers to how the Skintact® ECG Tab Electrodes with LecTec LT 4900 gel meet these established electrical requirements.
| Acceptance Criterion (from ANSI/AAMI EC 12:2000) | Reported Device Performance (Skintact® ECG Tab Electrodes with LecTec LT 4900 gel) |
|---|---|
| AC impedance requirement | Testing conducted, results show difference is negligible within limits |
| DC offset voltage requirement | Testing conducted, results show difference is negligible within limits |
| Defibrillation overload recovery requirement | Testing conducted, results show difference is negligible within limits |
| Combined offset instability and internal noise requirement | Testing conducted, results show difference is negligible within limits |
| Bias current tolerance requirement | Testing conducted, results show difference is negligible within limits |
| Biocompatibility (Cytotoxicity, Skin Irritation, Sensitization) | Confirmed materials are biocompatible with no adverse results |
| Shelf-life (24 months) | Real-time aging confirmed, supported by 20 years of experience with current packaging |
| Reliable signal tracing data | Three ECG tracings provided, demonstrating reliable signal tracing of consistent high quality |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the electrical tests (AC impedance, DC offset voltage, etc.), the document does not explicitly state the number of electrodes tested or the sample size used. For the clinical data, "Three ECG tracings using LecTec LT 4900 gel electrodes were provided."
- Data Provenance: Not specified, but generally, such testing is conducted in a controlled lab environment. The "clinical data" (ECG tracings) are generated using human subjects, but the location or specific characteristics of these subjects are not provided. The study is implicitly prospective as it involves testing the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for the electrical performance is defined by the ANSI/AAMI EC 12:2000 standard. The device's electrical characteristics are measured directly and compared to the standard's limits. For the clinical tracings, the "ground truth" is the visually assessed "reliable signal tracing of consistent high quality," implying expert qualitative assessment, but the number or qualifications of such experts are not stated.
4. Adjudication Method for the Test Set
Not applicable. The electrical tests are objective measurements compared against a standard. The "clinical data" is described qualitatively, implying a subjective assessment, but no formal adjudication method (like 2+1 or 3+1) is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC study was not done. This is a 510(k) for a physical medical device (ECG electrode), not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- Electrical Performance: Electrical measurement values compared against the quantitative limits specified in the ANSI/AAMI EC 12:2000 standard.
- Biocompatibility: Results from standardized biocompatibility tests (Cytotoxicity, Skin Irritation, Sensitization).
- Shelf-life: Real-time aging data and historical company experience.
- Clinical Data: Qualitative assessment of "reliable signal tracing of consistent high quality" from ECG tracings.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI device that requires a training set.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.